Device and Methods for Suturing Tissue

ABSTRACT

Systems for suturing a tissue layer having two sides with a suture be releasably retaining at least a portion of the suture in a stationary position on one side of the tissue layer. The portion of the suture is retrieved through the tissue layer from the opposite side whereby the suture is drawn from one side to the opposite side. Systems for suturing the wall of a tubular graft having two sides is also provided using a suture by releasably retaining at least a portion of the suture on one side of the wall. the portion of the length of suture is retrieved through the wall of the graft to the opposite side of the wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/737,668, filed Dec. 16, 2003, which is a continuation of U.S. patentapplication Ser. No. 10/033,689, filed Dec. 28, 2001, which is acontinuation of U.S. patent application Ser. No. 08/883,246, filed Jun.26, 1997, now U.S. Pat. No. 6,355,050, which is a continuation-in-partof U.S. patent application Ser. No. 08/824,031, filed Mar. 26, 1997, nowU.S. Pat. No. 6,036,699, which is a continuation-in-part of U.S. patentapplication Ser. No. 08/259,410, filed Jun. 14, 1994, now U.S. Pat. No.5,779,719, which is a divisional and a continuation-in-part of U.S.application Ser. No. 07/989,611, filed Dec. 10, 1992, now U.S. Pat. No.5,417,699. The disclosures of these prior applications are herebyincorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to devices and methods for thesuturing of tissue in various applications such as closure of arterialand venous puncture sites, suturing a graft anastomosis to an aperturein a vessel wall or other types of tissue, and the like. Moreparticularly, the inventive devices and methods provide for suturing thetissue of a vessel even though the vessel may be under physiologicalflow and while preferably maintaining hemostasis.

BACKGROUND OF THE INVENTION

A number of diagnostic and interventional vascular procedures are nowperformed transluminally, where a catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access which is usually established usingthe well known Seldinger technique, as described, for example, inWilliam Grossman's “Cardiac Catheterization and Angiography,” 3rd Ed.,Lea and Febiger, Philadelphia, 1986, incorporated herein by reference.

When vascular access is no longer required, the introducer sheath mustbe removed and bleeding at the puncture site stopped. One commonapproach to attempt providing hemostasis (the cessation of bleeding) isto apply external force near and upstream from the puncture site,typically by manual or “digital” compression. This approach suffers froma number of disadvantages. It is time-consuming, frequently requiringone-half hour or more of compression before hemostasis is assured. Thisprocedure is uncomfortable for the patient and frequently requiresadministering analgesics to be tolerable. Moreover, the application ofexcessive pressure can at times totally occlude the underlying bloodvessel, resulting in ischemia and/or thrombosis. Following manualcompression the patient is required to remain recumbent for at least sixand at times as long as eighteen hours under close observation to assurecontinued hemostasis. During this time renewed bleeding may occurresulting in bleeding through the tract, hematoma and/or pseudoaneurismformation as well as arteriovenous fistula formation. Thesecomplications may require blood transfusion and/or surgicalintervention. The incidence of these complications increases when thesheath size is increased and when the patient is anti-coagulated. It isclear that the standard technique for arterial closure can be risky, andis expensive and onerous to the patient. While the risk of suchconditions can be reduced by using highly trained individuals, such useis both expensive and inefficient.

To overcome the problems associated with manual compression, the use ofbioabsorbable fasteners to stop bleeding has been proposed by severalgroups. Generally, these approaches rely on the placement of athrombogenic and bioabsorbable material, such as collagen, at thesuperficial arterial wall over the puncture site. While potentiallyeffective, this approach suffers from a number of problems. It can bedifficult to properly locate the interface of the overlying tissue andthe adventitial surface of the blood vessel, and locating the fastenertoo far from that surface can result in failure to provide hemostasisand subsequent hematoma and/or pseudo aneurism formation. Conversely, ifthe fastener intrudes into the arterial lumen, intravascular clotsand/or collagen pieces with thrombus attached can form and embolizedownstream causing vascular occlusion. Also, thrombus formation on thesurface of a fastener protruding into the lumen can cause a stenosiswhich can obstruct normal blood flow. Other possible complicationsinclude infection as well as adverse reactions to the collagen implant.

Catheters are also used to treat heart disease which is a major medicalailment wherein arteries become narrowed or blocked with a build-up ofatherosclerotic plaque or clot which reduces flow to tissues downstreamor “distal” to the blockage. When this flow reduction becomessignificant, a patient's quality of life may be significantly reduced.In fact, heart disease patients often die when critical arteries, suchas the coronary arteries, become significantly blocked.

However, technology has been developed to open some blocked arteries inthe treatment of heart disease. For example, balloon angioplasty hasbecome a well accepted treatment wherein a balloon is inflated withinthe narrowed vessel to stretch or otherwise deform the blockage into alarger lumen. Attentively, the blockage can even be removed, such as ina procedure known as atherectomy. In general, these treatments usepercutaneous catheters which are inserted into the patients' vessels ata peripheral artery or vein puncture site and guided to the internalblockage site via x-ray visualization. The blockage is then treatedremotely by use of hydraulic pressure in the case of balloonangioplasty, or by other actuating means to cause remote cutting orablation of the blockage in the case of atherectomy.

Coronary Artery Bypass Graft Surgery (“CABG”)

In the alternative to using catheters to treat heart disease, or whensuch catheterizations are contraindicated, some blocked vessels can betreated with coronary artery bypass graft surgery (“CABG”). Inconventional CABG techniques, a tubular graft is affixed to a port oraperture in an artery wall distally of the blockage. When the oppositeend of the tube is in fluid communication with a pressurized arterialblood supply, such as the aorta, the tubular graft provides a conduitfor flow into the vessel lumen distally of the blockage.

Conventional CABG surgery is generally initiated by directly exposingthe heart to the surgeon. This is accomplished by opening the patient'schest using known sternotomy and retraction techniques that cut thesternum and spread the rib cage open. Then, one or both lungs areusually deflated and the patient is connected to a respiratory assistmachine.

Once the heart is exposed, the patient is connected to a coronary bypassmachine so that the blood supply circumvents the heart. In this way, theheart is depressurized so that apertures can be cut into the walls ofthe vessels for surgical graft attachment. The right atrium (or venacava) and the aorta each is intubated with cannulas which are connectedto an artificial pump and oxygenator. Once these major vessels arecannulated, cardioplegia is delivered to slow or stop the beating motionof the heart. The aorta is then clamped proximally of the aortic bypasscannula, thereby isolating the proximal aortic root from the blood thatis being circulated by the bypass machine.

After the heart is isolated from blood pressure, conventional bypassgrafting is performed. The required grafts are implanted to feed thecoronary arteries distal to the blockage, the clamp is removed from theaorta, the lungs are restored, and the patient is then taken off of thebypass pump.

In one type of CABG method, the bypass grafting is achieved between theaorta and one of the three major coronary arteries or theirsub-branches, the left anterior descending artery (LAD), the circumflexartery (CIRC), or the right coronary artery (RCA). In such a case, asaphenous vein is usually taken from the patient's leg and istransplanted as a “homograft” to connect these vessels in the samepatient's chest. Artificial grafts have also been disclosed as providingpotential utility for this purpose and are herein collectively includedin the general discussion of “saphenous veins” as used in CABGprocedures.

An alternative CABG method uses the internal mammary artery (IMA) aloneor in conjunction with the saphenous vein graft. The IMA is severed at achosen location and is then connected to an aperture, in a coronaryartery.

In either case of using saphenous vein homografts or artificial graftsin CABG surgery, the proximal end of the graft is generally sutured orotherwise is affixed circumferentially to the tissue surrounding anaperture that is punched into the wall of the aorta. In thisarrangement, the lumen of the graft communicates with the vessel throughthe aperture, wherein ideally the aperture approximates the innerdiameter of the graft lumen. The opposite, distal end of the graft issutured to an aperture formed in the wall of the coronary vessel distalto the blockage.

The fluid connections between a graft and a vessel are herein referredto as “anastomoses.” In the instance of CABG, “proximal anastomoses” and“distal anastomoses” are terms used when referring to grafting to theaorta and the coronary artery, respectively. In most CABG proceduresusing saphenous vein grafts, the distal anastomosis is performed first,followed by the proximal anastomosis.

For the CABG method using the IMA, only one distal anastomosis is formeddistal to the arterial blockage. A proximal anastomosis to the aorta isnot required as it is in a saphenous vein graft procedure because theIMA's natural arterial blood flow feeds the heart.

In conventional CABG surgery methods such as those just summarized, thetiming and technique of the anastomosis procedures are critical factorsto procedural success. In fact, it is believed that three criticaldeterminants which affect outcomes of CABG surgery are: (1) time thepatient spends on bypass, (2) time the patient spends with a clampedaorta, and (3) the quality of the anastomoses. It is generally believedthat a CABG patient's operative and peri-operative morbidity aredirectly related to how long the patient must be on heart bypass. Infact, it is generally understood that the risk of patient morbidity isbelieved to rise significantly after a threshold time of one hour onbypass. Perhaps the most prevalent complication arising from prolongedcardiac bypass is the high risk of distal thrombus created by theartificial plumbing. For example, such thrombi can embolize into theneurovasculature and potentially can cause a stroke. In analyzing thetiming of individual CABG steps against the backdrop of a patient'scritical time on bypass, the time spent anastomosing the grafts tovessels emerges as a controlling factor. The average time for suturingone anastomosis is approximately 7-10 minutes. Furthermore, it isbelieved that an average CABG procedure involves approximately fiveanastomoses: two saphenous vein grafts, each with a proximal and adistal anastomosis, and one internal mammary artery having only onedistal anastomosis. Therefore, the average time for graft suturingranges from 35 minutes to 50 minutes—in any case a significant portionof the 60 minute critical threshold to patient morbidity. Closelyrelated to the time spent on bypass is a second CABG success factorrelated to the extent and time of aortic cross-clamping. It is believedthat the inherent crushing force from a cross-clamp across the bridge ofthe muscular aortic arch may be associated with a high degree of tissuetrauma and structural damage. Additionally, hemostasis formed at oradjacent to the cross clamp, perhaps in conjunction with the tissuetrauma of clamping, may also be a source of unwanted thrombogenesis.

In addition to the timing of anastomosing grafts and extent and durationof aortic cross-clamping, the quality of interface between the graft andvessel is also believed to be an indicator of procedural success. Theaccuracy, trauma, and repeatability of suturing, as well as thethree-dimensional interface formed between the conduits at theanastomosis site, are significant variables in conventional manualsurgical techniques. These variables are believed to significantlyaffect the short or long-term success of conventional CABG anastomosisprocedures.

Limitations of Conventional CABG Devices & Methods

Both of the critical CABG success indicators summarized above—time oncardiac bypass and quality of anastomosis suturing—are directly affectedby inherent limitations in the devices used in conventional CABGprocedures. It is believed that improvements to these devices andrelated methods of use may provide for more rapid and reliablevessel-graft anastomosing. For example, conventional “surgical punches”are devices that cut or “punch” a plug in vessel wall tissue to form anaperture in the wall. In a CABG procedure, the tissue surrounding apunched-out aperture provides the substrate upon which a graft may besutured to form an anastomosis. One procedural limitation in usingconventional surgical punches is that hemostasis can not be maintainedat a vessel wall after a plug of tissue is punched out and removed.Therefore, an aperture in an aortic wall during a saphenous vein graftprocedure can only be made when that portion of the aorta iscross-clamped, bypassed, and depressurized. Otherwise, the high bloodpressure and flow in the aorta would cause significant bleeding duringthe period from punching the aperture to forming the anastomosis.Because of this limitation in conventional surgical punches, thethreshold 60 minute coronary bypass clock begins running before punchingthe aorta.

The prior art fails to disclose or fulfill the need which exists in thefield of medical devices and methods for: suturing tissue by proximallydrawing sutures through a tissue layer in the proximity of an aperture;suturing tissue by reversibly advancing needles from one side of atissue layer to retrieve one or more sutures on the opposite side of thetissue layer; a medical device assembly and method that automaticallyand repeatably places suture thread through vessel wall tissuesurrounding an aperture in the vessel wall in a suture pattern that isuseful for anastomosing a tubular graft to the aperture; and a medicaldevice assembly that deploys a suture with one end extending through thetissue that surrounds a aperture in a vessel wall and the oppositesuture end extending radially through a tubular graft wall adjacent anopen end of the graft, such that a vessel anastomosis may be rapidly andrepeatably performed in a CABG procedure even while the vessel is underphysiological flow.

SUMMARY OF THE INVENTION

The present invention provides a device for suturing a tissue layerhaving two sides which includes a suture and means for releasablyretaining at least a portion of the suture in a stationary position onone side of the tissue layer. The device also includes means forretrieving the portion of the suture through the tissue layer from theopposite side whereby the suture is drawn from one side to the oppositeside.

A device is also provided for suturing at least one tissue layer whereineach tissue layer has two sides. The device includes a fastener havingat least a first and second portion. The first and second portions havemeans for securing the first and second portions together. The first andsecond portions have a base at one end to prevent the respective portionfrom passing completely through the tissue layer. The device includesmeans for releasably retaining the first portion in a stationaryposition on one side of the tissue layer and means for driving thesecond portion through the tissue layer from the opposite side andsecurely engaging the securing means of the first and second portionswhereby the base of the first portion abuts one side of the tissue layerand the base of the second portion abuts the opposite side of the tissuelayer.

The present invention provides a device for suturing tissue in theproximity of an aperture in a tissue layer which include a shaft havinga proximal and distal end and a foot attached to the distal end of theshaft. The foot is adapted for advancing through the aperture. At leastone needle is carried above the distal end of the shaft. At least aportion of a suture is releasably retained on the foot in the proximityof the aperture. The device also includes means for reversibly advancingthe needle through the tissue to retrieve and draw at least a portion ofthe suture through the tissue. The advancing means is integrally formedwith the shaft.

A device for suturing the wall of a tubular graft having two sides isalso provided by the present invention. The device includes a suture,means for releasably retaining at least a portion of the suture on oneside of the wall, and means for retrieving the portion of the length ofsuture through the wall of the graft to the opposite side of the wall.

A graft anastomosis assembly is also provided for suturing a tubulargraft about an aperture in a tissue wall. The assembly includes asuture, a tissue suturing and graft suturing devices. The tissuesuturing device includes means for releasably retaining at least aportion of the suture in a stationary position on one side of the tissuelayer and means for retrieving the portion of the suture through thetissue layer from the opposite side whereby the suture is drawn from oneside to the opposite side. The graft suturing device includes means forreleasably retaining at least a portion of the suture on one side of thegraft and means for retrieving the portion of the length of suturethrough the wall of the graft to the opposite side of the graft.

A graft assembly for anastomosing a tubular graft and vessel is alsodisclosed herein. The graft having a graft wall that defines a graftlumen with an open end. The graft wall has a plurality of ports spacedin a predetermined pattern near the open end. The assembly includes aplurality of sutures in the predetermined pattern. Each suture has afirst suture portion extending through one of the plurality of ports inthe graft wall. Each suture has a second suture portion extending alongat least a portion of the graft lumen.

A method for suturing a tissue layer having two sides is also providedby the present invention. The steps of the method include: releasablyretaining at least a portion of a suture in a stationary position on oneside of the tissue layer; and retrieving at least a portion of thesuture through the tissue layer to the opposite side.

Another method of the present invention sutures tissue in the proximityof an aperture in a tissue wall. The steps of the method include:forming a port from the proximal side of the tissue wall; passing atleast a portion of a suture from the distal side of the tissue wallproximally through the port in the tissue wall in the proximity of theaperture; and forming a loop with the remaining portion of the suture tosecure the suture.

A further method for suturing an aperture in a vessel wall is providedherein. The steps of the method include: reversibly advancing aplurality of needles through the vessel wall to form ports in theproximity of the aperture; passing at least a portion of a sutureproximally through the ports in the vessel wall disposed on oppositesides of the aperture from the interior of the vessel with the remainingportion of the suture passing out of the vessel; and securing the endsof the suture to close the aperture.

Another method of the present invention sutures the wall of a tubulargraft to define a graft lumen and an open graft end. The steps of themethod include: releasably retaining at least a portion of a suturewithin the graft lumen and adjacent the graft open end; puncturing thetubular graft wall with the plurality of needles to form a plurality ofports in a circumferential pattern; and drawing the portion of sutureoutwardly from the graft lumen and through each of the plurality ofports and external of the graft wall.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which comprise a portion of this disclosure but are notto scale:

FIG. 1 is a perspective view of an embodiment of a suturing deviceconstructed in accordance with the principles of the present invention;

FIG. 2A is a detail view of the distal end of the guide body of thesuturing device of FIG. 1, shown with the needles retracted fully withinthe guide body;

FIG. 2B is a view similar to FIG. 2A, except that the needles have beenpartially drawn back into the guide body;

FIG. 3 is a cross-sectional view of the device of FIGS. 2A and 2B, takenalong line 3-3 of FIG. 2B;

FIGS. 4-7 illustrate the method of the present invention using thesuturing device 30 of FIG. 1;

FIG. 8 illustrates the X-pattern of the tied suture applied by thesuturing device;

FIG. 9 is a perspective view of a tissue suturing device of the presentinvention inserted through a tissue layer;

FIG. 10 is an isolated perspective view of the needle carrier and footof the tissue suturing device in FIG. 9;

FIG. 11 is a top view of the foot of the tissue suturing device in FIG.9;

FIG. 12 is a side view of the foot and shaft of the tissue suturingdevice in FIG. 9 inserted through a tissue layer;

FIG. 13 is an isolated perspective view of an alternate embodiment ofthe shaft and foot of the tissue suturing device;

FIG. 14A is a cross-sectional view of the foot along the lines 14A-D inFIG. 13 illustrating an example of one cross-sectional shape for thefoot;

FIG. 14B is a cross-sectional view of the foot along the lines 14A-D inFIG. 13 illustrating another example of one cross-sectional shape forthe foot;

FIG. 14C is a cross-sectional view of the foot along the lines 14A-D inFIG. 13 illustrating another example of one cross-sectional shape forthe foot;

FIG. 14D is a cross-sectional view of the foot along the lines 14A-D inFIG. 13 illustrating another example of one cross-sectional shape forthe foot;

FIG. 15 is a side view isolating the engagement of a needle and sutureof the tissue suturing device illustrated in FIG. 9;

FIG. 16 is a cross-sectional view of the needle and suture in FIG. 15along the lines 16-16 with the needle and suture in an engaged position;

FIG. 17 is a top view of the needle and suture in FIG. 15 along thelines 17-17 with the needle and suture in an engaged position;

FIG. 18A is a side view of the suture end illustrating an example of aball shape for the suture end;

FIG. 18B is a side view of the suture end illustrating an example of asolid cuff shape for the suture end;

FIG. 18C is a side view of the suture end illustrating an example of aring shape for the suture end;

FIG. 18D is a side view of the suture end illustrating an example of aserrated cuff shape having slits for the suture end;

FIG. 18E is a side view of the suture end illustrating an example of ahook shape for the suture end;

FIG. 19A is a side view of a serrated needle tip illustrating an exampleof a retrieving device of the present invention;

FIG. 19B is a side view of a needle tip and tubing assembly illustratingan example of another retrieving device of the present invention;

FIG. 19C is a side view of a needle tip with an indentation illustratingan example of another retrieving device of the present invention;

FIG. 19D is a side view of a hook-shaped needle tip illustrating anexample of another retrieving device of the present invention;

FIG. 19E is a side view of a needle tip and tubing assembly illustratingan example of another retrieving device of the present invention;

FIG. 20 is a cross-sectional view of two tissue layers being joined bythe present invention using a multi-piece fastener in a tissue suturingdevice;

FIG. 21 is a cross-sectional view of a tissue layer and suture beingjoined by the present invention using a multi-piece fastener in a tissuesuturing device;

FIG. 22 is a cross-sectional view of a suture cuff attached to twolengths of a suture for use with the present invention;

FIG. 23 is a top view of an isolated section of tissue layer having asuture pattern therein formed by a continuous suture used with thepresent invention;

FIG. 24 is a top view of an isolated section of tissue layer having apurse-string suture pattern therein formed by a single suture used withthe present invention;

FIG. 25 is a perspective view of another embodiment of a tissue suturingdevice of the present invention;

FIG. 26 is an isolated top view of the foot of the tissue suturingdevice of FIG. 25;

FIG. 27 is a cross-sectional view of an alternate button embodiment forretrieving a suture loop in the foot of the present invention;

FIG. 28 is a top view of a tear shaped button embodiment for retrievinga suture loop in the foot of the present invention;

FIG. 29 is a cross-sectional view of the button embodiment in FIG. 27for retrieving a suture loop in the foot of the present invention;

FIG. 30 is a diagrammatic side view of another embodiment of a tissuesuturing device of the present invention utilizing a needle carrier andneedle retrieval arrangement positioned at an obtuse angle to thelongitudinal axis of the device;

FIG. 31 is a perspective view of an anastomoses assembly of the presentinvention;

FIG. 32 is an isolated perspective view of the graft suturing devicefrom the assembly in FIG. 31;

FIG. 33 is another embodiment of a graft suturing device of the presentinvention which retrieves sutures inwardly through a graft wall;

FIG. 34 is another embodiment of a graft suturing device of the presentinvention which positions the graft through the needle carrier;

FIG. 35 is a perspective view of another embodiment of the graftsuturing device of the present invention which retrieves the sutures inan axial direction;

FIG. 36 is a cross sectional view of a needle driving device forretrieving the sutures illustrated in FIG. 35;

FIG. 37 is a side view of an alternate arrangement for driving theneedles as illustrated in FIG. 36;

FIG. 38 is a cross-sectional view of a vessel illustrating the insertionof a foot of the inventive tissue suturing device from a remote accesssite;

FIG. 39 is a cross-sectional view of a vessel illustrating the insertionof a foot of the inventive tissue suturing device from a remote accesssite; and

FIG. 40 is a cross-sectional view of a vessel illustrating the insertionof another embodiment of a foot of the inventive tissue suturing devicefrom a remote access site.

DETAILED DESCRIPTION

As used herein, the term “distal” is generally defined as in thedirection of the patient, or away from a user of a device, or in adownstream direction relative to a forward flow of blood. In the contextof a medical device intervention with or through a vessel wall, “distal”herein refers to the interior or the lumen side of the vessel wall.

Conversely, “proximal” generally means away from the patient, or towardthe user, or in an upstream direction relative to a forward flow ofblood. In the context of a medical device intervention with or through avessel wall, “proximal” herein refers to the exterior or outer side ofthe vessel wall.

Additionally, “oblong” is herein intended to mean oval, elliptical, orotherwise having a generally rounded shape that is not perfectlycircular. In particular, the term describes the shape of a tubular graftend cut at an acute angle relative to the plane perpendicular to thetissue walls defining the graft.

The term “hemostasis” is herein used to mean the arrest of bleeding orsubstantially blocking flow of blood outwardly from a vessel lumen whilethe vessel lumen is pressurized or sustaining physiological blood flow.This amount of blockage or occlusion to flow is further defined suchthat the blood loss which is experienced is less than an amount whichwould affect procedural methods or outcomes according to a physicianuser of a device of ordinary skill in the art. In other words,“hemostasis” is not intended to mean only “total hemostasis” such thatthere is a total lack of blood loss. Rather, the term is used to alsomean “procedural hemostasis” as a relative term in its use amongphysicians of ordinary skill.

Similarly, “occlusion,” “occlude,” “blockage,” “block . . . plugging”,“block,” or variations thereof are all terms which are herein intendedto have a procedurally relevant definition in the context of their use.For instance, an aperture is “occluded” although there is somemeasurable flow therethrough, but that flow is so low such that theintended procedural benefit of occlusion is at least partially achieved.Certainly, such terms also properly include within their scope a “totaleffect” definition, as well.

The term “perfusion” is herein used to mean the flow of blood or otherunit of perfusate (the fluid used for perfusion) per unit volume oftissue. Physiological perfusion refers to the amount of blood flowpresent when the body is functioning normally. For example,physiological perfusion usually prevents clinically significant STelevations which is one of the most sensitive indicators of inadequateperfusion. Adequate perfusion refers to the amount of blood flow thatavoids the clinical requirement of transfusing the patient or that isneeded to prevent tissue necrosis distal to the aperture in the bloodvessel.

The term “suturing” is herein intended to include the process of joiningtwo surfaces or edges together with a fasten r so as to close anaperture, opening, or wound or join tissues. The fastener is usually asuture such as a thread of material (either polymeric or natural), gut,wire or the like. The term fastener as used herein also includes clamps,studs, hasps, catches, hooks, rivets, staples, snaps, stitches, VELCROC,buttons, and other coupling members.

Referring to FIGS. 1-3, a suture applying device 400 which is suitablefor suturing and sealing of percutaneous vascular puncture site,particularly those made to the femoral artery in a patient's groin, willbe described. It will be appreciated, however, that the device of thepresent invention can be readily adapted for use with punctures made toother hollow body organs and lumens, although it may be necessary tomodify the dimensions and other particular aspects of the device toaccommodate the different usage environment.

The device 400 comprises a guide body 402 and a needle shaft 404. Theguide body 402 includes a guide tip 406 at its distal end, which guidetip includes a plurality of guide channels 408 which receive theproximal ends of needles 410. An aligning arrow 403 is mounted on handle405 located at the proximal end of the guide body 402. A marker lumenbubble 407 is located below the aligning arrow and serves to indicatewhen the distal end of the guide body has entered a blood vessel, asdescribed in the embodiment below. An indicator lumen 411 which permitsthe flow of blood to the marker lumen bubble 407 is illustrated in FIGS.2A and 2B.

The needles 410 as illustrated comprise a sharpened tip section 412 andan elongate shank portion 414, but may also be manufactured as anintegral piece. The shank portion 414 will be sufficiently long so thatthe needles may be pushed from their butt end by a support holster 428fixedly attached to the needle shaft 404 in order to advance the needlesthrough the tissue to be sutured and fully through the guide body 402inserted together with support sheath 440 in the associated tract sothat no capture mechanism will be required.

The guide body 402 further includes a plurality of needle lumens 420which are axially aligned and spaced about the periphery of the guidebody. As best seen in FIG. 2B, the needles 410 will enter the distalends of the lumens 420 as the needles are advanced proximally relativeto the guide body.

A flexible needle sheath 426 will be attached to the guide tip 406 ofguide body 402. The central lumen of the needle sheath 426 receives asupport holster 428 attached to the distal end of the needle shaft 404,as well as the needles 410. As with previous embodiments, the butts ofthe needles 410 are removably received within the support holster 428.The sheath 426 will be sufficiently long to permit the needles to extendat least 5 cm beyond the distal end of guide body 402.

Prior to use, the suture applying device 400 will be in theconfiguration illustrated in FIGS. 1 and 2A. That is, the needle shaft404 will be distally positioned within the guide body 402 and needlesheath 426. In particular, the tips of needles 412 will lie just at theguide tip 406 so that they may be easily advanced through the arterialtissue surrounding the arteriotomy. That is, the tips of the needleswill be generally retracted within the guide tip 406. A length of suture422 is attached to the proximal tips 412 of opposed pairs of needles410, with the connecting suture being stored in side lumens 427extending axially along the exterior of the needle sheath 426. As bestobserved in FIGS. 2A and 2B, the suture 422 extending between one pairof opposed needles is received in a first of the side lumens 427, whilethe suture extending between the other pair of opposed needles isreceived in the second of the side lumens. While it would be possible tostore the suture 422 in the lumens 420 of the guide body 402 (and thuseliminate the need for side lumens 427), such storage is less preferredsince it increases the risk that the suture will become entangled withthe needles 410 as they are withdrawn proximally. The use of side lumens427 greatly simplifies feeding of the suture as the needles 410 arewithdrawn.

After the guide tip 406 has been passed through the puncture site to besutured, the needles may then be drawn proximally forward through thetissue to be sutured by drawing proximally on handle 430 at the proximalend of needle shaft 404. The method of the present invention will now bedescribed in more detail with reference to FIGS. 4-7.

The situation following an interventional or other vascular procedure,where the attending physician is satisfied that the puncture site may besealed, is illustrated in FIG. 4. A conventional introducer sheath is inplace with a guidewire passing into the femoral artery. The conventionalintroducer sheath is withdrawn after assuring that an appropriateguidewire for the suturing process is in place. The device 400(including a support sheath 440 which initially covers the ports to theneedle lumens 420) will then be introduced over the guidewire, asillustrated in FIG. 4. The needles 410 and sutures 422 mostly encased byflexible needle sheath 426, will be fully advanced into the femoralartery FA past the arterial puncture site A. Handle 441 on supportsheath 440 is then partially withdrawn proximally to expose the needlelumens 420 (as shown in FIGS. 2A, 2B, and 5). Handle 430 will then bedrawn proximally outward relative to the guide body 402, causing theneedles 410 to pass through the superficial wall of the femoral arteryFA and into the needle lumens 420, as illustrated in FIGS. 2B and 5. Thehandle 430 may continue to be drawn proximally (i.e., outward from thepatient) in order to continue to pull the needle shaft 404 through theguide body 402. Such movement of the needle shaft 404, in turn,continues to draw the needles 410 outward through the lumens 420 of theguide body 402 until the tips of the needles are exposed. The user maythen grasp the needles and continue to draw them out until the suture isavailable to the user. The guide body 402 may then be withdrawn from thesupport sheath 440, leaving a portion of the needle sheath 426 still inthe puncture site A to maintain hemostasis. The suture can then be tiedand the knot pushed back down through the support sheath 440. The knotwill then only be tightened when the needle sheath is finally withdrawnfrom the puncture site A.

It can be seen that the guide tip 406 deflects the needles radiallyoutward so that the pattern of four needles engages the artery wall inan approximately square pattern about the arteriotomy A. After thesutures are tied and the knots advanced back through the support sheath440, the resulting pattern of tied suture will appear as in FIG. 8 whenviewed towards adventitial surface of the femoral artery FA surroundingthe arteriotomy A.

Device 400 has certain advantages over the previous embodiments. Sinceit is not necessary to capture the needles using an internal capturemechanism, the needles need not have barbs. Such barbless needles willminimize trauma to the arterial tissue around the puncture site A andsimplify the procedure. The guide body 402 and guide tip 406 aredesigned as an integral structure to assure that needles 410 will beprecisely centered around the puncture site A, and will very reliablyenter the needle lumens 420 in guide body 402. Also, tip 406 willocclude the arteriotomy puncture during the performance of theprocedure, providing hemostasis. Moreover, the entire procedure issimplified, with fewer discrete steps being performed. The user needonly introduce the device over-the-wire and thereafter draw out theneedle shaft to carry the needles through the tissue to be sutured andoutward through the guide body, where the suture becomes accessible andmay be tied in a conventional manner.

The present invention also provides several devices which comprise agraft anastomosis assembly. One of the preferred embodiments of thegraft anastomosis assembly and component devices depicted in thedrawings is inserted through an aperture or hole in a tissue wall, suchas the wall of the distal artery, an aorta, or other vascular tissue.The assembly mechanically places a predetermined pattern of sutures inthe tissue wall. The aperture can then be enlarged manually or,optionally, by the assembly itself, such that the suture pattern is inclose proximity to the circumference of the aperture. The assemblyprovides a graft to the tissue wall at the site of the aperture.Preferably, hemostasis is maintained during a substantial portion of theprocedure. Furthermore, the graft anastomosis assembly and devices canmaintain perfusion beyond the area of the device introduction throughthe vascular tissue.

A preferred embodiment of one component for the graft anastomosisassembly is a tissue suturing device 10 shown in FIGS. 9-12 whichreliably deploys a uniform suture pattern in a tissue wall 12 defining ablood vessel 14. The tissue suturing device 10 is useable separately forsuturing any type of tissue, whether or not as part of an anastomosesprocedure. On the other hand, the tissue suturing device 10 can be usedto deploy sutures in either, or both, the blood vessel and graft in ananastomosis procedure. Optionally, the tissue suturing device 10 caninterlock with a graft suturing device, as will be discussed below, toprovide alignment between the suture patterns in the tissue wall 12 anda graft wall.

The tissue suturing device 10 includes an elongated body 16 having adistal end 18 and proximal end 20. Referring specifically to FIG. 9, thetissue suturing device 10 includes a hand grip 22 partially nestedwithin the elongated body 16 and externally accessible to an operator.The device 10 also includes a needle carrier 24, a foot 26 attached to ashaft 28 which extends proximally into the elongated body 16, and anactuating mechanism referred to generally as 30. Supported within theelongated body 16, the actuating mechanism 30 attaches to the hand grip22 as illustrated by the cut-away portion.

The actuating mechanism 30 includes a cam 32 which is rotatably securedto the elongated body 16 by a fastener 34. The cam 32 is integrallyformed with the hand grip 22 and pivots in the directions indicated byarrows 36 using the fastener 34 as the pivot point. The cam 32 includesa slot 38 located between the hand grip 22 and the fastener 34 andextending through the cam itself. The cam 32 slidably connects to theproximal end 40 of the needle carrier 24 by engaging a peg 42 which isaffixed to the needle carrier 24 and extends perpendicularly therefrom.Moving the hand grip 22 in the direction of the arrows 36, pivots thecam 32 and slides the peg 42 along the slot 38. As a result, the needlecarrier 24 travels along the shaft 28 within the elongated body 16 andreversibly moves the distal end 44 of the needle carrier toward the foot26.

As specifically illustrated in FIG. 10, the distal end 44 of the needlecarrier includes an integrally formed cutting blade 46 mounted on asurface approximating the size of the circumference of the foot 26. Oneend 48 of the cutting blade is positioned near the shaft 28 so as tomeet the circumference of an initial aperture 52 formed in the tissuewall (as shown in FIG. 9). Preferably, the cutting blade end 48 rides ina longitudinal groove 54 (as shown in FIG. 11) formed in the shaft 28 asthe distal end 44 of the needle carrier and the foot 26 are squeezedtogether. The opposite end 50 of the cutting blade is positioned toenlarge the initial aperture 52 in the direction extending away from theshaft 28. The cutting blade 46 preferably has a height profile whichdecreases from the one end 48 of the cutting blade near the shaft to theopposite end 50 to form a decreasing gradient or slant. The decreasinggradient of the cutting blade 46 allows the end 48 of the cutting bladeto first engage and cut the tissue wall 12 near the shaft 28. Thecutting blade enlarges the incision toward the opposite end 50 as thedistal end 44 of the needle carrier and foot 26 are squeezedprogressively together. The present invention also includes embodimentswherein the cutting blade 46 has a uniform height across its length or agradient which is increasing from the cutting blade end 48 near theshaft to the opposite end 50 of the cutting blade.

Although one embodiment of the cutting blade 46 and the actuatingmechanism 30 is illustrated, alternative embodiments are suitable foruse with the present invention as may be apparent to one of ordinaryskill in the art. A variety of suitable punch/cutting devices, such ascircular blades, anvils, and the like, as well as actuating mechanisms,are disclosed in the following prior documents which are herebyincorporated in their entirety by reference thereto: U.S. Pat. Nos.3,104,666; 3,776,237; 4,018,228; 4,216,776; and 5,192,294 and U.S. Des.Pat. No. 372,310.

The distal end 44 of the needle carrier includes a plurality of needles56 attached thereto and extending in a generally perpendiculardirection. The needles 56 are arranged in a predetermined pattern whichmatches a desired corresponding suture pattern 58 (as seen in FIG. 12).The needles 56 are positioned at approximately uniform intervals aroundthe circumference of the initial aperture 52 which is enlarged toaccommodate a graft (not shown). The height of each of the needles 56from the surface of the distal end 44 of the needle carrier to its tipis slightly higher than the height of the cutting blade 46 so that theneedles 56 engage the tissue wall 12 just as, or slightly before, thecutting blade 46 engages the tissue wall 12. Having the needles 56engage the tissue wall 12 before, or simultaneously with, the cuttingblade 46, allows the tissue wall 12 to be captured and retained inposition to form the desired suture pattern 58 even after the cuttingblade 46 enlarges the initial aperture 52. The circumference of theenlarged aperture is retained in apposition as the cutting blade 46completes the incision.

The foot 26 has a top surface 60 and an opposing bottom surface 62 asseen in FIG. 11. The top surface 60 faces the distal end 44 of theneedle carrier and has a groove 64 which corresponds in position to thecutting blade 46 on the distal end 44 of the needle carrier. The groove64 is of sufficient size to accommodate a portion of the cutting blade46 below the plane of the top surface 60 to facilitate the making of theincision. The groove 64 has the same depth profile from one end 66 ofthe groove near the shaft 28 to the opposite end 68 as the heightprofile of the cutting blade 46. Located near the circumference 70 ofthe top surface 60 is a plurality of suture channels 72 extendingthrough the depth of the foot 26 to the bottom surface 62. The patternof the suture channels 72 on the top surface 60 corresponds to thepattern of needles 56 on the distal end 44 of the needle carrier (asseen in FIG. 10). As the distal end 44 of the needle carrier travelstoward the top surface 60 of the foot, the needles 56 have sufficientheight relative to the length of travel by the needle carrier 24 toslightly penetrate the suture channels 72.

Each of the suture channels 72 in the foot are sized to releasablyretain a suture 74 having a suture body or length 78 terminating at oneend 76. Preferably, the end 76 of the suture is releasably retained inone of the suture channels 72. As illustrated in FIG. 10, a plurality ofthe sutures lengths 78 extend downward through a lumen 80 in the shaft28 emerging through a distal shaft aperture 82. As each suture length 78emerges from the shaft, it is positioned within one of a plurality ofsuture grooves 84 within the bottom surface 62 of the foot. Each suturegroove 84 extends at least partially from the distal shaft aperture 82to a respective suture channel 72. The depth of each suture groove 84 issufficient to accommodate the width of the suture length 78 to provide aflush profile to the bottom surface 62. The end of each suture 76extends to the respective channel 72 where it is releasably retainednear the top surface 60 of the foot. Although it is preferred toposition the suture end 76 approximately flush with the top surface 60of the foot, it is suitable for the suture end 76 to be in any positionwhere it can be retrieved or engaged by the corresponding needle 56 orother retrieving device or means when the actuating mechanism 30squeezes the foot 26 and the distal end 44 of the needle carriertogether.

Although a plurality of needles 56 are illustrated on the needle carrier24 in a one-to-one correspondence with the suture channels 72 on thefoot 26, the present invention also provides other embodiments. Forexample, a single needle or a subset of needles less than the number ofsuture channels can be used on the needle carrier. The single needle orsubset of needles engages a corresponding number of suture channels witha first stroke bringing the foot and needle carrier together. Uponretrieving a corresponding number of sutures, the single needle orneedle subset is rotated to a new position after each stroke bringingthe foot and needle carrier together along the shaft 28. Rather thanhaving the needles deploy simultaneously with a single stroke, amulti-stroke, successive deployment is used.

Referring to FIG. 9, the suture lengths 78 extend toward the proximalend 20 of the elongated body. The suture lengths 78 exit from the lumen80 and pass through a longitudinal slot 86 (also illustrated in FIG. 10)which extends along the length of the shaft 28 and the distal end 44 ofthe needle carrier. Optionally, the suture lengths 78 extend from thelongitudinal slot 86 to a guide 88 which organizes the sutures. Theguide 88 is located on the external surface of the elongated body nearthe distal end. The suture lengths 78 extend through a second guide 90to a suture holder 92. The second guide 90 is located near the proximalend 20 of the elongated body. The suture holder 92 releasably retainsthe opposite ends 94 of the suture lengths so they may be individuallyidentified as to their position in the suture pattern 58 and retrievedby the operator.

The longitudinal slot 86 allows the removal of the foot 26 from theaperture completed 52 in the tissue wall 12 and the subsequent removalof the suture lengths 78 so that each end, 76 and 94, of the sutures canbe fastened together. In an alternate embodiment, the suture lengths 78extend internally along the length of the elongated body 16 toward theproximal end 20. A seam 98 along the length of the elongated body 16connects to the end of the longitudinal slot 86 so that the elongatedbody can be split open to remove the suture lengths 78 once the suturepattern 58 has been completed. The longitudinal slot 86 itself can alsobe replaced with a seam to similarly split the shaft 28, foot 26, andneedle carrier 24 to remove the suture lengths 78 from the lumen 80.

Preferably, the suture pattern 58 is a uniform distance from theperimeter of the completed aperture 52 in the tissue wall. Usually, theinitial aperture 52 is a simple longitudinal incision. Preferably, thepresent invention adjusts for the distance which the tissue wall 12surrounding the shaft 28 is offset. As illustrated in FIGS. 10 and 11,the foot 26 is partially defined by opposing side walls 100 and endwalls which define a heel 102 and toe 104 for the foot. The side walls100 bulge slightly outward in the vicinity of the shaft 28.Specifically, the distance between the circumference of the shaft andthe side walls 100 is the same as the distance from the cutting bladegroove 64 or longitudinal axis of the foot 26 to the side walls 100along the remainder of the foot. Like the remaining suture channels 72,the suture channels in the vicinity of the bulge, like 106 and 108, arelocated at the circumference of the side walls 100 which offsets suturechannels 106, 108 in the suture pattern 58. The offset suture channels106, 108 provide a uniform amount of tissue wall capture around theentire perimeter of the completed aperture 52 by adjusting the positionof the suture pattern 58 for the offset of the tissue wall 12 on eachside of the shaft 28. Usually, the tissue wall 12 is negligibly offsetby the shaft 28 in the direction of the heel end wall 102 because theshaft is positioned toward or at the heel end wall 102 of the incisioncreating the initial aperture 52. To further minimize the offset of thetissue wall 12 caused by the shaft 28, it is preferred that the shafthave an oval shape to its cross-section as specifically illustrated inFIG. 11.

The needles 56 on the surface of the distal end 44 of the needle carrierwhich correspond to the offset suture channels 106, 108 on the foot aresimilarly offset. The surface of the distal end 44 of the needle carrierin the vicinity of the shaft 28 is offset or bulges in a similar patternas the opposing side walls 100 of the foot.

FIG. 12 illustrates a side view of the foot 26 upon insertion throughthe initial aperture 52 in the tissue wall 12. Preferably, the toe endwall 104 is inserted first and moved forward. The shaft has a cut-awayportion 110 near its distal end to allow forward movement of the footassisting the insertion of the heel end wall 102 through the tissue wall12. The heel end wall 102 is then moved back slightly to abut one end ofthe initial aperture 52. The top surface 60 of the foot 26 abuts thedistal side 112 of the tissue wall promoting uniform tissue capture whenthe needles engage the top surface 60 of the foot. As the foot 26 passesthrough the tissue wall 12, the dilated tissue around the aperture 52usually responds elastically and compresses onto the shaft 28, therebymaintaining hemostasis. Once in position, the top surface 60 of the footlies adjacent the distal side 112 of the tissue wall, allowing adequateperfusion beneath the bottom surface 62 of the foot and the vessel wallintima 114. When the assembly is used on vascular tissue, the perimeterof the shaft is preferably about equal to the perimeter of the incision.For example, using the tissue suturing device 10 to perform ananastomosis on the distal artery places the diameter of the shaft in apreferred range of about 1.5 mm to about 2 mm which is the generallyaccepted diameter of the distal artery.

In those operations where the initial aperture 52 is formed by incisingthe tissue wall 12 or punching a hole of a size approximating thediameter of the shaft 28 in the tissue wall, there is significantly lessoffset of the tissue wall in the vicinity of the shaft. As a result, anearly uniform suture pattern 58 is formed without the foot 26 havingoffset suture channels. As illustrated in FIG. 13, the present inventionincludes an embodiment of the foot 26 which does not have an offset orbulge in the side walls 100 in the vicinity of the shaft 28. The samereference numerals are used for like components illustrated in the otherfigures. FIG. 13 also illustrates the shaft 28 having a more roundcross-section shape. The foot 26 can be formed in many other shapes andsizes while employing the inventive concepts described herein to aparticular surgical procedure, suture pattern, specific tissue, etc.

As illustrated in FIG. 14A, one preferred embodiment of the foot 26 hasa rounded shape to the corners and edges of the top 60 and bottom 62surfaces to provide for an atraumatic entry through the tissue wall andto guard against traumatizing the tissue wall intima opposite theaperture 52 upon advancing the foot 26 into the lumen of the bloodvessel 14 as previously seen in FIG. 12. Another example illustrated inFIG. 14B emphasizes an even more rounded bottom surface 62 than FIG. 14Ato guard against traumatizing the vessel wall intima 114 opposite theinitial aperture 52.

The foot 26 can also have several cross-sectional configurations asillustrated in FIGS. 14C and 14D for example, which provide a passageway115 along the longitudinal axis of the foot for perfusion when the foothas been inserted through the tissue wall 12 into a vessel 14 (as seenin FIG. 12). FIG. 14C provides the longitudinal passageway 115 along thelength of the foot 26 from the heel end wall 102 to the toe end wall104. FIG. 14D provides an example of a longitudinal passageway 115 toensure perfusion being used in combination with a curved top surface 60to the foot to minimize distortion of the proximal side of the tissuewall 12. A rounded bottom surface 62 prevents traumatizing the vesselwall intima 114 opposite the aperture 52. The suture channels 72 arepositioned at an angle to the top surface 60 of the foot so that theyare still perpendicular to the needles 56 on a corresponding needlecarrier 24 (as seen in FIG. 10).

Other examples of perfusion passageways include pathways which have abaffled or tortuous path. A coiled path is another example of anon-straight perfusion passageway.

Turning now to FIGS. 15-17, the relationship between the sutures 74 andneedles 56 is described in more detail. One end 76 of each of thesutures preferably terminates with a cuff 116 attached to the suturelength 78 along a bottom exterior wall 118. The cuff 116 has a generallycup-shape interior space 120 defined by a side interior wall 122 and abottom interior wall 124. The interior space 120 is sized to accommodateone of the needles 56 in a press-fit engagement. The distal end 126 ofeach needle has an arrowhead shape with a tip 128 and one or more barbs130. The arrowhead is mounted on a needle shaft 132 which has a taperedsection 134 near the arrowhead.

As specifically illustrated by FIGS. 16 and 17, when the needle 56engages the interior space 120 of the cuff, the diameter of thearrowhead barb 130 is sized to be slightly larger than the interiordiameter of the cuff interior space 120. As a result, the cuff side wall122 deflects slightly as the arrowhead barb 130 is inserted into theinterior space. The deflected side wall 122 is biased against the barb130 to provide a retaining force. The tip 128 of the arrowhead continuesuntil the interior side 124 of the bottom wall is engaged as a backstopto prevent further insertion of the arrowhead tip 128. Penetration ofthe tip 128 into the interior bottom wall 124 is not required to providean engaging force between the needle 56 and the suture 74.

For the sake of example, and not to be limited thereby, the preferreddimensions of the needle 56 are in a range of about a 0.01 inch to abouta 0.02 inch needle shaft 132 diameter which decreases to a diameter ofabout 0.005 inch in a tapered section 134. The length of the taperedsection 134 at the narrowest diameter is about 0.005 inch with anoverall length of about 0.013 inch. The diameter of the arrowhead barb130 is in the range of about 0.007 to about 0.008 inch. The height ofthe arrowhead barb 130 is in the range of about 0.010 inch to about0.014 inch. The height of the interior side of the side wall 122 isabout 0.02 inch with the cuff 116 having an overall height of about 0.03inch. The diameter of the interior space 120 from the interior side ofthe side wall 122 is about 0.005 inch. The thickness of the side wall122 is about 0.0025 inch and the bottom wall 118 is about 0.01 inch. Thedimensions of each suture channel 72 in the foot 26 for this particularexample have an interior diameter at the top surface 60 of the foot ofabout 0.011 inch.

The suture cuff 116 is preferably welded to the suture length 78 ormolded as one-piece from polypropylene. The cuff 116 can be made fromother medical polymers or malleable metals with a preferred hardness toprovide the retaining force by allowing the arrowhead barb 130 of aneedle 56 to deflect and bias the side wall 122 of the cuff againstitself and/or allow the barbs 130 of a needle to penetrate the side wall122 of the cuff.

Other means of attaching the suture length 78 to the cuff 116 are alsosuitable for use in the present invention such as attaching the cuff tothe suture length with a conventional adhesive like cyanoacrylate or byforming the cuff with an indentation in the exterior side 118 of thebottom wall and crimping the suture length therein. In anotherembodiment, the bottom wall 124 of the cuff can be made of the same, ordifferent, polymer which exhibits a surface hardness sufficient toresist penetration of the tip 128 and provide a backstop preventingexcessive penetration. The cuff 116 may also be initially molded as asolid block and subsequently bore an interior space 120 into the solidblock to complete the cuff.

Preferably, the suture length 78 is a single strand or monofilament.Although a multi-stranded, covered, twisted, or braided suture length isalso suitable for use with the present invention. The cuff 116 is alsopreferably removable from the suture length 78. A suitable rupturestrength of the cuff and suture length attachment is about 2 ounces toabout 10 ounces so that the two may be separated with the application ofa sharp tug.

The present invention provides other configurations for the suture end76. Illustrated for the sake of example, and not for limitation, FIGS.18A-E are suture ends 76 which can be retrieved or fetched by aretrieving device. The suture end 76 in FIG. 18A includes a suturelength 78 having a ball-shaped end 136 which is made of a soft material.Similarly, the suture end 76 in FIG. 18B includes a suture length 78attached to a solid cuff 138 made of a soft material.

The suture end 76 of FIG. 18C includes the suture length 78 attached ina perpendicular manner to one side of a ring 140. Made of deformablematerial, the ring 140 compresses in the suture channel (not shown) asthe larger diameter arrowhead barb is inserted entirely through the hole142 so that the ring is positioned above the barbs in the taperedsection of the needle shaft. As the compressed material relaxes, thering 140 is retained in the tapered section as the needle is withdrawnthrough the tissue wall. One end 144 of the ring is preferably taperedto allow for easy passage through the tissue layer. Another example of aretrieving device for use with the ring 140 is a hook as describedfurther below.

The suture end 76 of FIG. 18D includes the suture length 78 attached toa cuff 146 defined by a serrated side-wall 148 providing slits 150therein. The barbs of the needle previously discussed easily deform theside wall 148 and at least partially fill into one or more of the slits150 to provide a solid engagement therebetween.

The suture end 76 of FIG. 18E includes the suture length 78 whichterminates in a hook-shaped end 152 made of a material sufficiently hardto resist flexing as it is pulled through the tissue layer.Configurations of the suture end like the hook-shaped end 152 can beengaged by a retrieving device like, for example, a similarly shapedhook or by passing the hook-shaped end through the center of aretrieving device having a ring shape.

Other configurations of the retrieving device provided by the presentinvention are illustrated for example, and not limitation, in FIGS.19A-E. Preferably, the retrieving device of the present inventiongenerally includes means for forming a port in the tissue layer throughwhich a suture, or other fastener, is retrieved or introduced. Thesuture or fastener usually remains within the port.

Specifically, another configuration suitable for impaling the suture-endis illustrated in FIG. 19A as a serrated needle tip 154 effectivelyusing a plurality of barbs like 156, 158 at various positions andelevations along the shaft 132 of the needle to engage the suture end.

FIG. 19B retrieves the suture length 78 with a multiple piece assembly160 having the needle shaft 132 with a tapered section 134 near the tip128. A separate piece of tubing 162 in the tapered section 134 isinitially retracted towards the upper portion 164 of the tapered sectionuntil the suture length 78 is biased into an indentation 166 in thebottom 168 of the tapered section. As the needle shaft 132 is withdrawn,the tubing 162 slides downward to the bottom 168 of the tapered sectionand over the suture length 78 to retain it in place. The tubing 162 canfurther be configured to have an offset 170 at its bottom end toaccommodate the thickness of the suture length 78 while simultaneouslycovering the portion of the suture resting in the indentation 166.Optionally, the needle shaft 132 having the tapered section 134 can beused without the tubing 162.

FIG. 19C shows the suture length 78 retained within an indentation 172of the otherwise barbless needle shaft 132 with the aid of a suture loop174 formed in the shape of a noose with a clasp 176. In place of theclasp 176, the noose can also be formed by tying a knot in the sutureloop 174.

Another example of a retrieving device is illustrated in FIG. 19D withthe needle shaft 132 having a hook-shaped end 178 with a tip 180suitable for piercing the tissue layer. Optionally, the hook-shaped end178 can further include an inwardly facing barb 182 for assistance inretaining the suture end within the bight of the hook-shaped end.Examples of a suture end suitable for use with the hook-shaped end 178are shown in FIGS. 18C and 18E.

FIG. 19E illustrates another retrieving device having a cannula with alumen or tube 184 with a removable piercing element such as a needle 186located within the interior of the tube. The needle 186 is initiallyused to form a port in the tissue layer to atraumatically introduce thetube 184 through the tissue within the proximity of the suture end. Theneedle 186 is subsequently removed and the interior of the tube 184 isplaced under a vacuum sufficient to draw the suture end to the end 188of the tube. The tube 184 engaged to the suture end is then drawnthrough the tissue layer. Examples of a suture end suitable for use withthe tube 184 are shown in FIGS. 18A and 18B.

The present invention provides other means for engaging a portion of afastener through a tissue layer from the side opposite means forretaining another portion of the fastener in a stationary position. Thepresent invention provides for using a variety of fasteners to formdifferent types of suture patterns. Other examples of the engaging meansfor a fastener are illustrated in FIGS. 20 and 21.

In FIG. 20 a first tissue layer 200 and second tissue layer 202 arejoined by releasably retaining a first portion of a fastener 204 in astationary position on one side of the first tissue layer. As previouslydescribed, the first portion 204 can be releasably retained in the foot26 of a tissue suturing device. A second portion of the fastener 206 isreleasably retained in the distal end 44 of the needle carrier of thetissue device. The second portion 206 includes a needle tip 208 on aneedle shaft 210 for piercing and forming a port 212 in the first andsecond tissue layers. The second portion 206 also includes a base 214for abutting the second tissue layer 202 and a barb 216 on the needleshaft for engaging and being retained in an indentation 218 formed inthe first fastener portion 204. The first fastener portion 204 includesa face 220 for abutting the first tissue layer 200. As the distal end 44of the needle carrier is squeezed toward the foot 26, the needle tip 208engages the indentation 218 and the first and second portions of thefastener 204, 206 are retained together. As a result, the first andsecond tissue layers 200 and 202 are held in apposition.

FIG. 21 illustrates a tissue lay r 222 and a suture 224 are joined byreleasably retaining a first portion of a fastener 204 in a stationaryposition on one side of the tissue layer 222. As previously described,the first portion 204 can be releasably retained in the foot 26 of atissue suturing device. A second portion of the fastener 206 isreleasably retained in the distal end 44 of the needle carrier of thetissue device. The second portion 206 includes a needle tip 208 on aneedle shaft 210 for piercing and forming a port 212 in the tissue layer222. The second portion 206 also includes a base 214 for abutting thetissue layer 222 and a portion of the suture 224. A barb 216 on theneedle shaft passes through an aperture 226 in the first fastenerportion 204 and is retained therein. The first fastener portion 204includes a face 220 for abutting the opposite side of the tissue layer222. As the distal end 44 of the needle carrier is squeezed toward thefoot 26, the needle tip 208 passes through the aperture 226 and thefirst and second portions of the fastener 204, 206 are retainedtogether. As a result, the first and second portions of the fastenersecure the suture 224 therebetween.

The present invention is not limited to retrieving a suture only at itsend. As illustrated in FIG. 22, another embodiment of the cuff 116attaches directly to a suture length 78 and not the terminal end 76 ofthe suture forming two lengths 230, 232 of the suture extending from theexterior bottom wall 118 of the cuff. Although the cuff 116 can beintegrally formed as one-piece with the suture length 78, the cuff canbe attached to the suture length with a conventional adhesive. Thesuture length 78 can be one of a plurality of sutures that are deployedto form the suture pattern.

The suture length-cuff attachment illustrated in FIG. 22 can be used toform a suture pattern 58 in proximity to the aperture 52 in the tissuelayer as illustrated in FIGS. 23 and 24 using either a single or acontinuous suture. Using suture cuffs 116 periodically attached alongthe length of a continuous suture 234 as described in FIG. 22, the cuffs116 are releasably retained in the suture channels 72 of the foot 26 aspreviously described. The needles 56 penetrate the tissue wall 12forming a port 236 to engage each cuff 116, and pull each cuff throughthe tissue wall. Each cuff 116 is removed from the attached two ends230, 232 of the suture length to form a suture loop 238 which proximallyextends through and returns distally through the tissue wall at eachport 236. Each suture loop 238 is exposed on the proximal side 240 ofthe tissue wall can be utilized in several ways such as by attaching oneor more separate sutures like 242, fasteners, or anchors on the proximalside 240 of the tissue wall in order to attach a graft (not shown) or toclose the aperture 52. For example, a corresponding plurality ofseparate sutures such as 242 attached at one end to a graft can bepassed through each of the exposed suture loops 238. Each separatesuture 242 can also accommodate an anchor therethrough so that as thelengths 230 and 232 of the suture are pulled to draw each of the sutureloops 238 approximately flush with the proximal side 240 of the tissuewall. The separate sutures 242 can also be tightened to bring the graftin apposition with the proximal side 240 of the tissue wall. Theseparate sutures 242 can then be tied off.

As illustrated in FIG. 24, a purse-string suture pattern 246 inproximity to the aperture in the tissue layer uses a single suture 248having free ends 250. To prevent drawing the suture loops 238 completelythrough the tissue layer, a conventional anchor 244 is positionedunderneath each suture loop 238 at each port 236 and pulling the freeends 250 of the suture to draw the pattern closed. This suture pattern246 would be useful, for example, to close a puncture site or aperture52.

Another embodiment of the inventive tissue suturing device 310 is shownin FIGS. 25-26. The tissue suturing device 310 includes an elongatedbody 316 having a distal 318 and proximal 320 end. An actuatingmechanism (not shown for clarity) operates a foot 326 in a reversiblemotion against the distal end 344 of a needle carrier 324 using a shaft328. The distal end 344 of the needle carrier optionally includesintegrally formed cutting blades like 346 on each side of the shaftmounted on a surface approximating the size of the circumference of thefoot 326. The distal end 344 of the needle carrier includes a pluralityof needles 356 attached thereto and extending in a generallyperpendicular direction. The needles 356 are arranged in a predeterminedpattern which matches a corresponding suture pattern 358. The needles356 are positioned at approximately uniform intervals around thecircumference of the completed aperture which is being enlarged or slitto accommodate a graft (not shown). The height of each of the needles356 from the surface of the distal end 344 of the needle carrier to itstip is higher than the thickness of the tissue layer the needles 356 areanticipated to penetrate.

The foot 326 has a top surface 360 facing the distal end 344 of theneedle carrier and an opposing bottom surface 362. Located on the topsurface 360 is a plurality of suture channels 372 extending at leastpartially into the depth of the foot. The pattern of the suture channels372 on the top surface corresponds to the pattern of needles 356 on thedistal end 344 of the needle carrier. As the distal end 344 of theneedle carrier slides along the shaft 328 towards the foot, the needles356 on the distal end have sufficient height relative to the length oftravel by the needle carrier 324 to penetrate the suture channels 372.

Each of the suture channels 372 in the foot are sized to allow insertionby the tip 380 of the needles. The top surface 360 releasably retainsthe sutures, preferably loops 382 formed by one or more of the sutures.A plurality of suture lengths 378 extend downward through grooves 384 inthe shaft emerging along the top surface 360 of the foot to bepositioned within one of a plurality of suture grooves 386 within thetop surface of the foot. Each suture groove 386 extends at leastpartially from the grooves on the shaft to a respective channel 372. Thedepth of each suture groove 386 is sufficient to accommodate the widthof the suture to provide an approximately flush profile to the topsurface 360. Each suture length 378 extends to the respective channel372 where it is releasably retained near the top surface 360 of thefoot. Although it is preferred to position the suture length 378approximately flush with the top surface 360 of the foot, it is suitablefor the suture length 378 to be in any position where it can beretrieved by the corresponding needle 356 when the actuating mechanismsqueezes the foot 326 and distal end 344 of the needle carrier together.

As specifically shown in FIG. 26, each suture length 378 extends fromthe groove 386 in the top surface of the foot and forms the suture loop382 in a stationary position around the respective suture channel 372.The respective needle 356 travels in a perpendicular direction into thesuture channel 372. The suture loop is tensioned or biased towards theneedle 356, preferably by being positioned to slightly overlap the pathof travel expected for the needle 356. As the needle 356 is insertedinto the suture channel 372, the suture loop 382 is positioned to engagethe side of needle shaft 388 near the needle tip 380. As the needle 356continues its downward insertion, the suture loop 382 is pushed slightlyto one side until the needle 356 has been inserted sufficiently deep forthe indentation 390 in the side of the needle shaft 388 to reach thesuture loop 382. The tension on the suture loop 382 biases it toward theneedle shaft 388 so the suture loop slides into the indentation 390 inthe needle shaft given the opportunity for the suture loop to return toits initial position. It is not necessary to move the suture loop 382toward the needle shaft 388 to engage the indentation 390. Properposition of the suture loop 382 relative to the side of the needle shaft388 creates the desired bias to have the suture loop return to itsstarting position when the indentation 390 is adjacent the suture.Subsequently removing the needle 356 from the suture channel 372 backthrough the tissue layer pulls the suture loop along and passes itthrough the tissue layer.

Other embodiments of retaining the suture length 378 in the suturechannel 372 are shown in FIGS. 27-29. The suture channel 372 in the topsurface 360 of the foot retains a button 392 made of deformable materialin a press-fit. Alternately or in combination therewith, the button 392is supported from the inside of the foot by an elastic tube or spring394 which is positioned between the button and the bottom 362 of thefoot.

As specifically shown in FIG. 28, the button 392 has a preferredtear-drop shape so that the suture loop 382 fits between the bottom andthe edge of the suture channel 372. The suture loop 382 is tensioned orbiased against the button 392 as previously discussed. The button 392includes an outer surface having an indentation 396 accessible to theneedle 356 from the exterior side of the top surface 360 of the foot asseen in FIG. 27. As the needle tip 380 is inserted into the outersurface indentation 396, the button 392 is not depressed by the needle356 until the indentation 390 or barb of the needle shaft is about evenwith the outer surface of button to align the suture 382 with the barbor needle indentation 390. As seen in FIG. 29, the needle 356 furtherdepresses the button 392 which releases the suture loop 382 which slidesinto the barb or needle indentation 390. The needle 356 is withdrawn andpulls the suture loop 382 back through the suture channel 372 and,subsequently, through the tissue layer.

Although the embodiments of the tissue suturing device discussed aboveshow the needles 358 penetrating the tissue layer from a perpendiculardirection into a foot having a flat or planar top surface 360, thepresent invention is not so limited. Another embodiment 510 of theinventive tissue suturing device is shown in FIG. 30. The tissuesuturing device 510 includes an elongated body 516 having a distal end.An actuating mechanism (not shown for clarity) operates the foot 526 ina reversible motion against the distal end 544 of a needle carrier usingthe shaft 528. The distal end 544 of the needle carrier optionallyincludes integrally formed cutting blades 546. The distal end 544 of theneedle carrier includes a plurality of needles 556 attached thereto. Theneedles 556 are positioned near the circumference of the distal end 544of the needle carrier and extend downward toward the foot 526 and inwardtoward the shaft 528 forming an obtuse angle relative to the sidesurface of the elongated body 516.

The foot 526 has a curved top surface 560 facing the distal end 544 ofthe needle carrier and a curved opposing bottom surface 562. Located onthe top surface 560 is a plurality of suture channels 572 extending atleast partially into the depth of the foot 526. The pattern of thesuture channels 572 on the top surface 560 corresponds to the pattern ofneedles on the distal end 544 of the needle carrier. As the distal end544 of the needle carrier slides along the shaft 528 allowing the foot526 to travel towards the distal end, the needles 556 on the distal endhave sufficient height relative to the length of travel by the foot topenetrate the suture channels.

Each of the channels 572 in the foot are sized to allow insertion by thetip 580 of the needles. A plurality of suture lengths 578 extenddownward through grooves 584 in the shaft emerging along the top surface560 of the foot to be positioned within one of a plurality of suturegrooves within the top surface of the foot. Each suture length 578 ispositioned where it can be retrieved by the corresponding needle 556when the actuating mechanism squeezes the foot and distal end of theelongate body together in the manner described above.

Another preferred embodiment of a tissue suturing device 610 isillustrated in FIG. 31. The actuating mechanism 630 includes a motor 682secured to the elongated body 616. The motor 682 rotatably connects atone end to a worm gear 684 which connects to the proximal end 640 of theneedle carrier. The hand grip 622 includes a switch 686 connected to themotor 682 to control the direction and number of revolutions by the wormgear 684. Activating the switch 686 energizes the motor 682 to turn theworm gear 684 and advance the needle carrier 624 along the shaft 628within the elongated body 616. Once the needle carrier 624 has advancedto retrieve the sutures in the foot 626, the motor 682 is stopped bymanually deactivating the switch 686 or by using an automatic cut-off.The switch 686 can then be activated to have the motor 682 turn the wormgear 684 in the opposite direction and reverse the travel of the needlecarrier 624 to pass the sutures proximally through the tissue. A powersource 688 for the motor 682 is included within the elongated body 616although an external power source can also be used.

FIG. 31 also illustrates a graft anastomoses assembly 700 which includesa graft suturing device 710 as a second component. A preferredembodiment of the graft suturing device 710 is illustrated in FIGS. 31and 32. The graft suturing device 710 reliably deploys a uniform graftsuture pattern in a graft wall. The graft suturing device 710 is useableseparately for suturing any type of graft, whether or not as part of ananastomoses procedure. Optionally, the graft suturing device 710 caninterlock with a tissue suturing device like 610 to provide alignmentbetween the suture patterns in the tissue wall and a graft wall Thegraft suturing device 710 includes a graft needle carrier 724, a graftfoot 726 attached to a shaft 728 which extends into the elongated body616 of the tissue suturing device 610, and the actuating mechanism 630which can be the same as used by the tissue suturing device 610.

The graft needle carrier 724 includes a distal end 744 having a mountingsurface with an integral cutting blade 746 thereon. The cutting blade746 has a circular shape. The distal end 744 of the needle carrierincludes a plurality of graft needles 756 attached thereto and extendingin a generally perpendicular direction. The graft needles 756 arearranged in a predetermined pattern which matches a corresponding graftsuture pattern 758. The graft needles 756 are positioned atapproximately uniform intervals around the circumference of the wall ofthe graft end 782 (as seen in FIG. 32). The height of each of the graftneedles 756 from the surface of the distal end 744 of the graft needlecarrier to its tip 780 is slightly higher than the height of the graftcutting blade so that the needles engage the graft wall just as, orslightly before, the edge of the cutting blade 746 engages the wall nearthe graft end 782. Having the needles 756 engage the wall near the graftend 782 before, or simultaneously with, the cutting blade 746 allows thewall of the graft end 782 to be captured and retained in position toform the desired suture pattern 758 even after the edge of the cuttingblade 746 cuts the wall near the graft end 782.

Another suitable embodiment of the cutting blade 746 preferably has adecreasing depth profile forming a decreasing gradient or slant from theone side of the graft needle carrier 724. The decreasing gradient allowsthe end of the cutting blade edge to engage and cut the graft end 782 inan oblong shape. The edge of the cutting blade makes the cut as thedistal end 744 and graft foot 726 are squeezed progressively together.The present invention also includes embodiments wherein the cuttingblade 746 has a uniform height across its length. An oblong shape orother desired shape can still be formed with a cutting blade 746 ofuniform height by changing the circular shape of the cutting blade onthe surface of the distal end 744 to the desired shape.

Referring specifically to FIG. 31, the graft foot 726 has a top surface760 facing the distal end 744 of the graft needle carrier and anopposing bottom surface. The top surface 760 has a graft groove whichcorresponds in position to the graft cutting blade on the distal end 744of the graft needle carrier. The graft groove is of sufficient size toaccommodate a portion of the edge of the graft cutting blade below theplane of the top surface to facilitate the making of the cut. Locatednear the circumference of the top surface is a plurality of suturechannels 772 extending through the depth of the graft foot to the bottomsurface. The pattern of the suture channels 772 on the top surfacecorresponds to the pattern of graft needles on the distal end 744 of thegraft needle carrier. As the distal end 744 of the graft needle carriertravels toward the top surface of the graft foot, the graft needles 756have sufficient height relative to the length of travel by the graftneedle carrier 724 to penetrate the channels 772.

Each of the suture channels 772 in the graft foot are sized toreleasably retain a suture length 778, preferably the end 776 of thesuture as previously described. Although it is preferred to position thesuture end 776 approximately flush with the top surface of the foot, itis suitable for the suture end to be in any position where it can beretrieved or engaged by the corresponding graft needle 756 or otherretrieving device or means when the actuating mechanism squeezes thefoot and the needle carrier together. The suture lengths 778 extendwithin a lumen 780 in the graft shaft 728 to the surface of the distalend 744 of the graft needle carrier where a slot in the cutting bladeallows the suture lengths 778 to extend to the external side of theelongated body 616 as previously described with regard to the tissuesuturing device 610. The graft shaft 728 extends to connect to the shaft628 of the tissue suturing device or can be integrally made as aone-piece member.

The actuating mechanism 630 connects to the graft needle carrier 724 inthe same manner as between the actuating mechanism and the needlecarrier 624 of the tissue suturing device 610 in any of the embodimentspreviously described. FIG. 31 illustrates one such embodiment whereinthe actuating mechanism includes the motor 682 secured to the elongatedbody. The motor 682 rotatably connects on the opposite end to a secondworm gear 784 which connects to the proximal end 740 of the graft needlecarrier. The hand grip 622 includes a switch 686 connected to the motorto control the direction and number of revolutions by the worm gear.Activating the switch energizes the motor to turn the worm gear andadvance the needle carrier along the shaft within the elongated body.Once the graft needle carrier 724 has advanced to retrieve the sutureends 776 in the foot 726, the motor is stopped by manually deactivatingthe switch or by using an automatic cut-off. The switch 686 can then beactivated to have the motor turn the second worm gear 784 in theopposite direction and reverse the travel of the needle carrier to passthe sutures proximally through the tissue. Although one embodiment ofthe cutting blade and the actuating mechanism is illustrated,alternative embodiments are suitable for use with the present inventionas may be apparent to one of ordinary skill in is the art.

Two other embodiments of a graft suturing devices 810 are shown in FIGS.33-34 wherein the needles and suture channels are positioned on theopposite components of the device compared to the previously describedembodiments. The graft suturing devices 810 integrally mounts the foot826 on the proximal end 820 of the elongated body 816. A shaft 828extends from the proximal end 820 of the elongated body 816 to connectto the needle carrier 824 and to an actuating mechanism (not shown). Agraft 800 is pulled over the needle carrier 824 and extends toward thefoot 826. The foot 826 includes suture channels 872 which releasablyretain sutures 874 and are in alignment with needles 856 on the needlecarrier. As previously described, the needles 856 move axially to engagethe sutures 874 and retrieve the sutures through the graft 800.

Specifically, FIG. 33 ties one end 802 of the graft to the shaft 828with a tie 804. A cutting blade 846 is located inwardly of the needles856 toward the shaft 828. As a result, when the foot 826 and needlecarrier 824 are drawn together, the sutures 874 will be drawn throughthe graft 800 from the external wall 806 to the internal wall 808. Thesutures 874 can then be pulled out through the open end 802 of the graftonce the graft is removed from the needle carrier 824.

In FIG. 34, the graft 800 is positioned over the shaft 828 and pulledthrough the needles carrier 824. The graft 800 is further positionedover the top surface 860 of the foot to provide the cutting blade 846with proper alignment to cut the graft in the proximity of the end 802.Since the graft 800 extends through the needle carrier 824, an indexingdevice 830 provides the proper alignment for the needles 856 to engagethe sutures 874 and for the cutting blade 846 to cut the graft end 802.Optionally, the needle carrier 824 may be detachable from the remainderof the graft suturing device 810.

Another embodiment of a graft suturing device 910 is shown in FIGS.35-37 which includes a graft needle carrier 924, a graft foot 926attached to a shaft 928. Optionally, the graft shaft 928 may extend intothe graft anastomosis assembly. A graft 900 is positioned coaxiallyabout the graft foot 926 and held in position with a tie 909. The graftfoot 926 contains suture channels 972 for releasably retaining sutures974. The sutures 974 extend from the graft foot through suture grooves984. The suture channels 972 are positioned in an axial positionrelative to the longitudinal axis along the graft shaft 928. As aresult, the needles 956 carried by the needle carrier 924 must alsoretrieve the sutures 972 in an axial position The needles 956 aredeployed radially inwardly through the graft 900 in a regularly spacedpattern of penetration sites or ports in the graft.

FIG. 36 specifically illustrates the details of the graft suturingdevice that permits an inward radial deployment of the needles 956. Thegraft suturing device 910 further includes an outer cam 902 whichdeploys as a sleeve around the needle carrier 924 and needles 956. Thecam 902 includes ridges 904 and troughs 906 along a surface 908 of theinterior circumference of the cam. The cam 902 is rotated about thelongitudinal axis along the graft shaft 928 in either a clockwise orcounterclockwise direction as indicated by arrows 988. Each of theneedles 956 includes a tail 990 which abuts and slides along theinterior surface 908. The rotation of the cam 902 moves each of theneedles 956 in either an inward or outward direction as the tail 990encounters either the ridges 904 or troughs 906 respectively. Theneedles 956 are driven inwardly through the graft 900 to engage thesutures 974. Then the direction of the needles' movement is reversed andthe needles 956 move outwardly from the graft 900 with the sutures 974in tow. The return of the needles 956 to their initial position isassisted by a spring 992 coiled around the needles shaft. Subsequently,the sutures 974 can be released from the needles 956 and the graft 900can be removed from the cam 902 and graft foot 926.

As illustrated in FIG. 36, the needles 956 move simultaneously inward.In another embodiment, the needles can move inward successively bychanging the position of the ridges 904 and troughs 906 relative to eachone another.

Other embodiments of the cam 902 provide means for moving the needles956 outwardly without using a spring-like member. For example, FIG. 37illustrates using a rail 994 to which the tail 990 of one of the needlesis rotatably secured. As the cam 902 rotates in the direction of thearrows 988 and slides along the rail 994, the needle 956 is moved inwardand then is positively moved outward as the cam advanced. In a similarexample, the interior surface 908 can include the rail to which the tail990 of the needle is slidably attached. As the cam 902 is rotated, thetail 990 slides along the rail from trough 906 to ridge 904 and viceversa Since the tail 990 is positively attached to the interior surface908, the needle moves outward without the assistance of a spring-likemember.

Referring to FIG. 31, the graft suturing device 710 and the tissuesuturing device 610 can be used solely independent (one without theother) or operating together simultaneously or successively. Theinventive tissue suturing device 610 and inventive graft suturing device710 described herein can also be used solely independent with otherdevices or methods (conventional or not) to perform the other device'sfunction in anastomosis assembly and method. For example, the graftsuturing device 710 described in the related applications can be readilyadapted to interlock with the tissue suturing device 610 herein.

Preferably, the graft suturing device can be loaded with the graft priorto the insertion and operation of the tissue suturing device. The twodevices are then combined into one assembly to provide properorientation of the graft to the deployed suture pattern in the vesselwall. This results in a two-stroke method being used wherein one needlepasses the suture through the graft and a second needle passes thesuture through the vessel wall.

In another embodiment, a one-stroke method can be used with the presentinvention. For example, using only the vessel suturing device, theneedles can first pass the suture through the proximal side of the graftbefore they are attached to the distal Mend of the vessel suturingdevice. Then, as described above, the vessel suturing device is insertedthrough the vessel wall. The suture can then be passed through thedistal side of the vessel wall to complete the loop.

The present invention also provides a tissue suturing device and ananastomosis assembly which inserts a portion of the tissue suturingdevice from a remote access site other than the site of the tissuesuturing or anastomosis. Several embodiments of the tissue suturingand/or graft anastomosis assembly which uses a remote access site areillustrated in FIGS. 38-40.

FIGS. 38 and 40 illustrate a remote access site 1000 in the tissue wall1012 of a blood vessel 1014. A remote foot 1026 is introduced into theblood vessel 1014 through the remote access site 1000. The remote foot1026 is attached near its heel end wall 1002 to a guide wire 1004 whichis controlled at the other end by an actuating mechanism 1030.

The remote foot 1026 has a top surface 1060 with a groove 1064 thereonfor facing the distal end of a needle carrier and corresponding to theposition of a cutting blade as discussed herein. Located near thecircumference 1070 of the top surface 1060 is a plurality of suturechannels 1072 extending into the foot 1026. The pattern of the suturechannels 1072 on the top surface 1060 corresponds to the pattern ofneedles on the distal end of the needle carrier that will be attached tothe remote foot 1026 at the site where the suture pattern is desired.Each of the suture channels 1072 in the remote foot are sized toreleasably retain a suture 1074 having a suture body or length 1078terminating at one end 1076. Preferably, the end 1076 of the suture isreleasably retained in one of the suture channels 1072.

The sutures lengths 1078 extend across the top surface 1060 of theremote foot and to terminate at the bottom of a plug 1006. The plug 1006releasably retains the ends 1094 of the sutures 1074 opposite the sutureends 1076 retained in the suture channels 1072 so the suture ends 1094may be individually identified as to their position in the suturepattern and retrieved by the operator. The plug 1006 is detachable fromthe remote foot by the actuating mechanism 1030. Once the remote foot1026 has been guided to the desired cite of the suture pattern, the plug1006 is released from the remote foot by the actuating mechanism 1030and driven through the tissue wall 1012 of the blood vessel by areleasable connection to a second wire 1009 associated with the guidewires 1004 as seen in FIG. 39. To assist in making an initial aperture1052 through the tissue layer 1012 for the plug 1006 to pass through, adilating blade 1008 is preferably mounted on the top surface of theplug. The suture lengths 1078 have an excess amount of length sufficientto allow the plug 1006 to be pulled free of the blood vessel 1014. Theexcess amount of length is coiled within the remote foot 1026 beneaththe bottom surface of the plug 1006 before the plug is released. Afterthe plug 1006 has passed through the tissue wall 1012, the oppositesuture ends 1094 can be released.

With the release of the plug 1006, a depression 1098 corresponding tothe shape of the plug is left in the top surface 1060 of the remotefoot. This depression is adapted to securely receive the distal end of ashaft of a tissue suturing device (not shown) as previously describedherein. The shaft is advanced through the initial aperture 1052 into thedepression 1098. Attachment of the shaft of the tissue suturing deviceto the remote foot 1026 provides proper alignment of the needle carrierand needles of the tissue suturing device with the suture channels 1072of the remote foot.

Optionally, the plug 1006 can be another embodiment of the graft footpreviously discussed herein. Referring to FIG. 39, the plug 1006includes suture channels 1096 for releasably retaining the oppositesuture ends 1094. The suture channels 1096 are illustrated in an axialposition relative to the longitudinal axis. The plug 1006 can then beattached to the shaft or other positioning device on a graft suturingdevice as previously described herein specifically with regard to FIG.35.

An alternate embodiment of the plug 1006 positions the suture channels1096 along the longitudinal axis so that suture channels 1072 are flushwith the top surface of the plug 1006. With this configuration of suturechannels 1072, the plug can be attached to the shaft of a graft suturingdevice as previously described herein specifically with regard to FIG.31.

Another embodiment of a tissue suturing device and an anastomosisassembly which inserts a portion of the tissue suturing device from aremote access site other than the site of the tissue suturing oranastomosis is illustrated in FIG. 40. The tissue suturing device 1110in this embodiment uses a needle carrier 1124, a shaft 1128, and aremote foot 1126 as previously described with regard to the embodimentsof the non-remote tissue suturing device. The remote foot 1126, however,is attached to a rigid extension 1102 which connects at the other end tothe shaft 1128. Similarly, the needle carrier 1124 is attached to arigid extension 1104 which connects at the other end to the shaft 1128.The extensions 1102 and 1104 allow the remote foot 1126 to be insertedthrough the tissue layer 1112 into a blood vessel 1114 at a remoteaccess site 1100. As previously described with regard to the variousembodiments of the tissue suturing devices, the needle carrier 1124 hasa shape corresponding to the remote foot 1126 so that the needles 1156are aligned with the suture channels 1172.

The suture channels 1172 releasably retain sutures 1174 at one of theends 1176 while the suture lengths 1178 extend across the top surface1160 of the remote foot through suture grooves 1184 near the perimeterof the remote foot. The opposite ends 1194 of the sutures terminate in aplug 1106 which is releasably retained flush with the top surface 1160of the remote foot. One of the needles like 1157 on the needle carrieris aligned to retrieve the plug 1106 and draw it through the tissuelayer 1112. After the plug 1106 has been drawn through the tissue layer1112, the opposite ends 1194 of the sutures can be freed from the plug.

The tissue suturing device 1110 demonstrates that a suture pattern canbe deployed at a deployment site 1108 other than the remote access site.Furthermore, the tissue suturing device 1110 does not need an initialaperture at the suture deployment site 1108 in order to deploy thesuture pattern. The alignment between the needles 1156 and the suturechannels 1172 is provided by the extensions 1102 and 1104 without ashaft extending through an aperture at the deployment site 1108.

Optionally, a cutting blade 1146 can be mounted on the needle carrier1124 and is positioned to make an incision at the deployment site 1108to form an anastomosis site different from the remote access site 1100and not simply enlarge an initial insertion site. The cutting blade 1146is preferably aligned with the groove 1164 on the top surface 1160 ofthe remote foot and avoids contact with the suture lengths 1178. Ratherthan drawing the plug 1106 through a separate port in the tissue layer1112, the plug 1106 can be drawn through the incision made by thecutting blade 1146.

With the various inventive embodiments, alternate means of fastening thetwo ends of the suture body together are suitable. For example and notfor limitation, the two ends of the suture body can be simply tied in aknot manually or, optionally, with a knot device as is described incopending application U.S. Ser. No. 08/552,211 filed Nov. 2, 1995.

Even though the suture devices are illustrated herein with regard tovascular tissue, it should be understood that the present invention isriot limited to any particular type of tissue. Generally, the devices ofthe present invention can be used for suturing all types of tissue inmany applications. More specifically, the present invention can closeapertures in tissue or bind layers of tissue together such as inanastomoses. For example, and not for limitation, the present inventioncan be used to close apertures in the septum of the heart such as with aatrial septal defect or a patent foramen ovale. The present inventioncan deploy sutures around the annulus of a valve for the heart or otherorgans and around the proximity of a prosthesis.

The present invention can be used in anastomoses to provide a direct orindirect communication between two blood vessels, lymphatics, hollowviscera, or other tubular structures. Although the anastomoses betweenan aperture in a vessel wall and the end of a graft is specificallyillustrated, the present invention can also be used to anastomosetubular structures in other configurations such end-to-end, end-to-side,in continuity, conjoined, or closed-end. Examples of specificapplications include the CABG methods described herein using vessels andtubular grafts such as the aorta, veins, the internal mammary artery, orsuperficial temporal artery. An example of an anastomosis involving anorgan instead of a blood vessel is a Roux-en-Y operation which implantsthe distal end of the divided jejunum with the proximal end into theside of the jejunum at a suitable distance below the first to form aY-shape pattern.

The suturing devices described herein, particularly the tissue suturingdevices, can be used on grafts which do not have an open end. In someinstances, the open end of a graft is closed off by a clamp or otherclosure means. An incision is made in the graft to allow penetration ofthe foot of the tissue suturing device of the present invention into theside of the graft. The tissue suturing device deploys the desired suturepattern and is withdrawn from the graft. The suture pattern is availablefor attachment to a corresponding suture pattern or other fastenerarrangement. In an anastomoses procedure, the corresponding suturepattern is deployed on the selected vessel,

The present invention can be used with catheter-based surgicaltechniques wherein one of the elements of the devices described hereinis delivered to the suture site through a remote or alternate accesslocation. For example, the vessel suturing device described herein canbe introduced to the aorta through the femoral artery to the site wherethe sutures are deployed. The present invention allows indirectvisualization of the desired deployment site via marker ports, crystalsor the like.

While particular embodiments of the invention have been herein describedin detail, it is to be appreciated that the present inventionencompasses variations and combinations thereof, as may be apparent toone of ordinary skill from this disclosure. It is therefore to beunderstood that within the scope of the appended claims, the inventionmay be practiced otherwise than as specifically described herein.

1. A device for closing an opening in tissue, the device comprising: anelongated body having a proximal end and a distal end, a flexible sheathextending from the distal end of the elongated body and carrying alength of suture, with a cuff molded on an end of the length of suture,to close the opening in the tissue, the length of suture beingdeployable to penetrate the tissue wall, the elongated body beingadvanceable toward the opening along a guidewire to position the lengthof suture substantially adjacent the opening, and further comprising atleast one needle advanceable through tissue surrounding the opening todeploy the length of suture through the tissue wall, the cuff having aninner space adapted to receive a tip of one needle of the at least oneneedle following advancement of the at least one needle through thetissue.
 2. The device of claim 1, wherein the flexible sheath has adistal end, wherein the flexible sheath defines a guidewire entry portat or near the flexible sheath distal end, and wherein the flexiblesheath defines a guidewire exit port situated along the flexible sheathat a location proximal to the guidewire entry port.
 3. The device ofclaim 1, wherein the flexible sheath is sized to maintain hemostasis atthe opening when the flexible sheath is positioned through the opening.4. The device of claim 1, wherein the elongated body has a proximal endand a distal end, and further comprising a flexible sheath extendingfrom the distal end of the elongated body, the flexible sheath defininga suture storage lumen.
 5. The device of claim 1, wherein the needle hasa barbed end for insertion through the cuff to attach the needle to thelength of suture to deploy the suture through the tissue wall.
 6. Adevice for closing an opening in tissue, the device comprising: a shafthaving a proximal end and a distal end; a foot near the distal end ofthe shaft; a length of suture having an end and a cuff molded on the endof the suture, the cuff being releasably retained in the foot; and atleast one needle arranged on the device to be advanceable through thetissue surrounding the opening, the needle having a barbed end forinsertion through the cuff to attach the needle to the suture to drawthe suture through the tissue, the cuff having an inner space adapted toreceive a tip of one needle of the at least one needle followingadvancement of the at least one needle through the tissue.
 7. The deviceof claim 6, wherein the cuff is molded as one piece from the suturematerial.
 8. The device of claim 6, wherein the cuff is a ring and thelength of suture is attached in a perpendicular manner to one side ofthe ring.
 9. The device of claim 6, further comprising a flexible sheathextending from the distal end of the shaft, the flexible sheath defininga guidewire lumen.
 10. The device of claim 9, wherein the sheath definesa suture storage lumen.
 11. A method for closing an opening in tissue,the method comprising: advancing an elongated body, the elongated bodyhaving a proximal end, a distal end, at least one needle, and a flexiblesheath extending from the distal end of the elongated body and carryinga length of suture with a cuff molded on an end of the length of suture,along a guidewire to position the length of suture substantiallyadjacent the opening, advancing the at least one needle through tissuesurrounding the opening; and deploying the length of suture through thetissue wall, the cuff having an inner space adapted to receive a tip ofone needle of the at least one needle following advancement of the atleast one needle through the tissue through the opening.
 12. The methodof claim 11, further comprising partially withdrawing the elongated bodyleaving a portion of the flexible sheath in the opening to maintainhemostasis.
 13. The method of claim 11, further comprising advancing aneedle through the tissue adjacent the opening to attach the needle to alength of suture.
 14. The method of claim 13, further comprisingadvancing a barbed end of the needle through the cuff.
 15. The method ofclaim 11, wherein the flexible sheath defines a guidewire lumen, and themethod further comprises positioning a guidewire through the opening andloading the guidewire into the guidewire lumen to advance the flexiblesheath through the opening.
 16. A method for closing an opening intissue, the method comprising: providing a suturing device having ashaft, the shaft having a distal end; advancing at least a portion theshaft through the opening; positioning a length of suture on a distalside of the tissue, the suture having an end and a molded cuff on theend of the suture; advancing a needle through the tissue adjacent theopening and through the cuff to attach the needle to the length ofsuture; and withdrawing the needle and the suture through the tissue.17. The method of claim 16, further comprising providing a flexiblesheath on the distal end of the shaft.
 18. The method of claim 17,further comprising partially withdrawing the suturing device leaving aportion of the flexible sheath in the opening to maintain hemostasis.19. The method of claim 17, wherein the flexible sheath defines aguidewire lumen, and the method further comprises positioning aguidewire through the opening and loading the guidewire into theguidewire lumen to advance the suturing device through the opening. 20.The method of claim 16, further comprising tying a knot in the suture toclose the opening.
 21. A method for closing an opening in tissue, themethod comprising: inserting a guidewire through the opening in thetissue; providing a closing device adapted to penetrate the tissue andpermit closing of the opening carrying an implant with a cuff molded onan end of the implant; using the guidewire to guide a portion of theclosing device to a position substantially adjacent the opening; andpenetrating the tissue to at least partially close the opening.
 22. Themethod of claim 21, wherein penetrating the tissue to at least partiallyclose the opening includes deploying the implant.
 23. The method ofclaim 22, wherein the implant is a length of suture.
 24. The method ofclaim 22, further comprising providing a needle on the closing deviceand penetrating the tissue wall with the needle to advance the implantinto the tissue wall.
 25. The method of claim 24, further comprising:positioning a portion of the suture on a distal side of the tissue, themolded cuff releasably retained on the closing device; advancing theneedle through the tissue adjacent the opening and through the cuff toattach the needle to the length of suture; and withdrawing the needleand the suture through the tissue.